Company
United StatesInfoBionic, Inc., Chelmsford, MA – FDA Inspections
Inspection records and compliance data for InfoBionic, Inc. in Chelmsford, Massachusetts. 2 FDA inspections on record, 1 Form 483, last inspected November 17, 2022.
Company Profile
This profile covers InfoBionic, Inc. based in Chelmsford, Massachusetts, United States.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 1
- NAI
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected April 10, 2019. Last inspected November 17, 2022.
Most cited issue areas
- Design validation - Risk analysis1 inspection
- DHR - not or inadequately maintained1 inspection
- Documentation1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| November 17, 2022 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1194164 |
| April 10, 2019 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1085891 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
InfoBionic, Inc.
FEI Number
3010112812
Address
321 Billerica Rd Ste 5, Chelmsford, Massachusetts 01824, United States
Country
United States
ID: eacb0491-ba47-41dd-bfef-0b0062c9d473